- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911932
Investigating Genetic Status in Patients Presenting to Clinic
December 8, 2023 updated by: Elizabeth Finger, Lawson Health Research Institute
The causes of neurodegenerative dementias such as Frontotemporal Dementia, Lewy Body Disease and Alzheimer's disease are still largely unknown.
While the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified.
Further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown.
By examining genotypes in patients that present to our Cognitive Neurology and Alzheimer's Research Clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah Jesso
- Phone Number: 519-646-6000
- Email: cognitiveneurology@sjhc.london.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6C 0A7
- Recruiting
- Parkwood Institute
-
Contact:
- S Jesso, BA
- Phone Number: 519-646-6000
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);
Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
Description
Inclusion Criteria:
- Persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, AD, FTD, LBD, ALSP, and related conditions);
- Biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic;
- Age 18+ years old;
- Consenting to a blood draw.
Exclusion Criteria:
• Persons declining / unwilling / not able to have a blood draw.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood draw for genetic status or polymorphism result.
Time Frame: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
|
The blood draw is taken at the time of the clinic visit.
Up to 30ml will be collected by standard venipuncture.
|
A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic information.
Time Frame: A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
|
Demographic information will be collected at the time of the clinic visit.
|
A one-time visit, taking the participant approximately 20 minutes total for all study procedures.
|
Medical history/Clinical diagnoses.
Time Frame: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
|
Will be obtained via chart review when available.
This information is collected already as part of the patient's standard care.
|
Typically within 1 month of the clinic visit, taking approximately 5 minutes.
|
Pathological diagnoses.
Time Frame: Typically within 1 month of the clinic visit, taking approximately 5 minutes.
|
Will be obtained via chart review when available.
This information is collected already as part of the patient's standard care.
|
Typically within 1 month of the clinic visit, taking approximately 5 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Finger, MD, Lawson Health Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2023
Primary Completion (Estimated)
August 1, 2038
Study Completion (Estimated)
August 1, 2043
Study Registration Dates
First Submitted
June 12, 2023
First Submitted That Met QC Criteria
June 12, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Dementia
- Alzheimer Disease
- Lewy Body Disease
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- 121760
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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